Suppositories are a solid dosage form of medication, dietary supplement or botanical extract that can be delivered internally to a patient, human or animal, in situations where it is not desirable for the patient to take the dosage orally, parenterally or when a local effect is desired by insertion of the solid dosage form directly to the affected area of the body. Known types of suppositories include rectal, vaginal and urethral suppositories. Compounded suppositories are dosage forms that are prepared by physicians, pharmacists, technicians, paramedic personnel and the like to meet the specific requirements of an individually prescribed dosage. A compounded suppository normally consists of one or more drugs mixed with a base compound which are absorbed within the body after insertion into the body cavity. The compounding of suppositories refers to the preparation, mixing, assembling, and packaging of a solid dosage drug or the like, usually based on a medical prescription ordered by a physician.
Typically, compounded suppositories are created in a mold. The mold includes one or more mold cavities sized and shaped based on a desired dosage amount and location of the body where the suppository is to be received. In preparing the suppositories, typically a suppository base compound is melted and then one or more drugs are added to the melted base, creating a mixture that is poured into each of the suppository cavities of the mold. Alternatively, one or more drugs may be dissolved or suspended in a base compound, creating a drug/base mixture that is then melted and poured into each of the mold cavities. The suppositories are then cooled to solidify the drug/base mixture so that the solidified suppository may be removed from the mold for future dispensing to a patient.
Suppository molds may include anywhere from a few cavities for the formation of suppositories up to in excess of 100 cavities, depending upon the size of the mold and the dosage amount requirements. Molds commonly used for the preparation of suppositories include those made out of metal, such as an aluminum alloy, brass or a plated metal. Metal molds often consist of two mold halves with cavities formed in each mold half such that when the mold halves are placed together to form a single mold and the cavities from the two halves are aligned, the desired shape of the suppository is formed in the cavity. These metal molds are lubricated and chilled prior to adding the drug/base mixture to facilitate the formation of the suppositories and the subsequent removal of the suppositories from the metal mold.
After formation of the suppositories and removal of the suppositories from the metal mold, the mold must be cleaned prior to subsequent use so that residue from one batch of suppositories does not affect the dosage amount of subsequent suppository batches. Another reason why the mold must be cleaned after each use is to ensure the desired quality of the subsequent suppository composition is maintained, especially if a different suppository composition is prepared in the subsequent application. Additionally, after the individual suppositories are prepared in a metal mold, they are typically manually removed and stored, in an unprotected form, in a container that is then passed to a patient under prescription. The patient would then manually remove an individual dosage from the container of suppositories for administration. With this unprotected group storage and manual handling of the suppository at the preparation and dispensing phases, there lies an ongoing risk that the suppository dosage quantity or quality could be adversely affected by breakage of portions of the suppository or partial melting of the suppository in the hands of the preparer or end user.
Suppositories are alternatively prepared and stored in disposable plastic shell containers that are often connected in strip form for individual dispensing by a patient. These plastic shells are commonly made of a relatively soft plastic such as polystyrene. A series of shell containers may be laid out in strip form so that each of the containers may be filled with a drug and base mixture to form a suppository. The strip of plastic shells may include perforated sections between the shell containers so that an individual suppository dosage may be manually separated from the rest of the strip for administration, followed by disposal of the plastic shell container.
While these plastic shell containers allow for the preparation, storage and dispensing of compounded suppositories in a single container, they are not without disadvantages. Among the disadvantages of disposable plastic shells is that the plastic shell is generally pliable and thus easily deformable, which can impede the retention of a desired shape of the shell container and adversely affect the dosage amount or physical quality of the suppository itself. For example, a suppository within a plastic shell that has been partially dented or compressed may result in less than the complete suppository quantity being removable from the shell, which would result in less than the desired dosage of medication being available and possible difficulty in administering the suppository due to an altered physical structure of the suppository.